EUCTR2011-004388-62-PL进行中（未招募）不适用
A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate Efficacy of a Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in subjects with Gastroesophageal Reflux Disease (GERD) with Persistent Regurgitation With or Without Heartburn. - SPD557-206
Shire-Movetis NV0 个研究点目标入组 460 人开始时间: 2012年4月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 460
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Written Informed Consent Form signed voluntarily before the first study-related activity.
- •2.Aged between 18 and 70 years, inclusive.
- •3.Subjects with a history of the cardinal symptoms of GERD (both heartburn and regurgitation) prior to PPI therapy.
- •4.Subjects with symptoms of GERD for at least 6 months prior to the Screening Visit.
- •5.Subjects who have persistent symptoms of regurgitation for 3 or more days over the past week with or without heartburn while on PPI.
- •6.Subjects have at least some improvement to the symptom of heartburn while on PPI therapy.
- •7.Subjects on PPI therapy for at least 8 weeks prior to the Screening Visit of which the last 4 weeks are on a stable labeled dose for any GERD indication according to the country label, where a change of PPI therapy would not impact the symptoms (twice-daily dosing of PPI is not allowed in the last 4 weeks)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 383
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 77
排除标准
- •1.Subjects who show no response to heartburn while on PPI therapy.
- •2.Subjects with dyspepsia symptoms that are more predominant than their GERD symptoms (heartburn and/or regurgitation).
- •3.Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.
- •4.Presence of severe and clinically uncontrolled cardiovascular, liver, lung or neurologic disease, cancer or AIDS.
- •5.Alarm symptoms suggestive of malignancies or organic disease.
研究者
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